Hormone refractory prostate cancer MedDRA version: 14.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Janssen Oncology, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Willing and able to provide written informed consent. Written Authorization for Use and Release of Health and Research Study Information (US) or Data Protection Consent (EU) has been obtained . Completed 12 cycles of abiraterone acetate under study COU-AA-003. Last dose of abiraterone acetate is within 14 days of the anticipated commencement of study treatment should the patient meet all other eligibility criteria. Serum potassium = 3.5 mmol/L. Eastern Cooperative Oncology Group (ECOG) Performance Status of = 3. (Karnofsky Performance Status = 30%). Able to swallow the abiraterone acetate capsules whole. Able to follow study instructions, accessible for treatment and follow-up, and likely to complete all study requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection, Uncontrolled hypertension. Abnormal liver function tests consisting of any of the following: Serum bilirubin > 1.5 x ULN ALT > 2.5 x ULN AST > 2.5 x ULN Clinically significant heart disease as evidenced by a myocardial infarction in the past twelve months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease. Patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least two years prior to enrolment and after consultation with a cardiologist to insure that the disease is stable. Current enrolment in an investigational drug or device study or participation in such a study within 30 days of Cycle 13 Day 1 other than abiraterone acetate study COU-AA-003. Patients who have partners of childbearing potential who are not willing to use a method of birth control determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration. Condition or situation which, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient’s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide additional treatment of abiraterone acetate (CB7630) to patients who have completed 12 cycles of abiraterone acetate treatment and continue to receive clinical benefit from such treatment.; Secondary Objective: To continue to evaluate the safety of abiraterone acetate. To continue to evaluate the efficacy of abiraterone acetate ; Primary end point(s): Study treatment will end when patient dies, is lost to follow-up, withdraws informed consent, experiences sustained side-effects, has disease progression or if Cougar Biotechnology decides to terminate development of CB7630. Upon discontinuation from trial, the patient will continue to be followed for overall survival. Overall survival follow-up should be performed every 12 weeks by telephone interview or chart review for up to 3 years. Disease progression as defined by PSA measurements will be based on a progressively rising PSA according to PSAWG (PCWG1) criteria. Disease progression in soft tissue or bone will be defined by RECIST criteria based on assessments on bone scan, x-ray, CT scan, or MRI or physical examination. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trials Manager
Janssen Oncology, Inc.
Outcome results
None listed